Biotech business confirms green light to commercialise Covid test
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has confirmed registration of Avacta’s AffiDX® SARS-CoV-2 antigen lateral flow test, allowing the company to place it on the market.
The lateral flow antigen test has been designed to provide a cost effective and rapid means of identifying individuals with high viral loads – which means they are more likely to infect others – of Covid-19. It received “excellent results” at recent clinical trials in Europe, with the firm noting it is “excited by the potential” for the product.
The news comes after confusion last month when a Twitter user, @StickyStock81, published an e-mail that appeared to be from the MHRA which said the CE mark application for the test had been rejected on May 20, leading to a share sell-off.
The Wetherby-based business which has “multiple ongoing commercial discussions” is now expecting registration from the Competent Authority within the EU to follow shortly.
Dr Alastair Smith, chief wxecutive officer of Avacta Group, said: “I am delighted to receive confirmation of the registration of the AffiDX® SARS-CoV-2 antigen test from the MHRA. It is a transformative milestone for Avacta’s Diagnostics Division being the first CE marked product powered by the Affimer® platform that has been brought to market.
“We are very excited by the potential of this high-quality SARS-CoV-2 rapid antigen test and by the interest it has already attracted from potential commercial partners and distributors. We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.
“Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX® test will now play a significant part in this process.”
